article dict | reports listlengths 1 3.97k |
|---|---|
{
"abstract": "OBJECTIVE\nThe aim of this study was to explore the effects of early oral ibuprofen administration on the incidence of hemodynamically significant patent ductus arteriosus (hsPDA) and define the association between serum ibuprofen levels and ductal closure.\n\n\nMETHODS\nPreterm infants with a gestatio... | [
{
"companynumb": "US-JNJFOC-20150219051",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "IBUPROFEN"
},
"drugadditional": null,
"... |
{
"abstract": "Cystic fibrosis (CF) patients receive many antibiotic treatments for recurrent respiratory infections and frequently report antibiotic hypersensitivity reactions (HSRs). In this retrospective study, medical records of CF patients were reviewed to clarify the clinical features, the culprit antibiotics, ... | [
{
"companynumb": "FR-TEVA-2020-FR-1503934",
"fulfillexpeditecriteria": "1",
"occurcountry": "FR",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "SULFAMETHOXAZOLE\\TRIMETHOPRIM"
},
"drugadditio... |
{
"abstract": "The long-term efficacy of infliximab in patients with Crohn's disease is suboptimal.\n\n\n\nTo study prognostic factors for real-life long-term effcacy of infliximab in Crohn's disease.\n\n\n\nAll consecutive Crohn's disease patients treated with infliximab at a tertiary centre were retrospectively ana... | [
{
"companynumb": "BE-JNJFOC-20160913574",
"fulfillexpeditecriteria": "1",
"occurcountry": "BE",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "INFLIXIMAB"
},
"drugadditional": null,
... |
{
"abstract": "In 2003, van Grotel and colleagues reported an infant suffering a chemotherapy-resistant eRMS of the tongue, that was treated with subtotal tumor resection and brachytherapy after major medical ethical discussions. As no long-term sequelae of such a procedure have been described, perspectives were unce... | [
{
"companynumb": "NL-ACCORD-061501",
"fulfillexpeditecriteria": "1",
"occurcountry": "NL",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "ETOPOSIDE"
},
"drugadditional": "3",
"drugad... |
{
"abstract": "A 17-year-old male subject with a history of deep venous thrombosis presented with acute unilateral severe chest pain. His examination was nonspecific, and vital signs were normal. His initial laboratory evaluation revealed mild thrombocytopenia, elevated troponin levels, and critically elevated activa... | [
{
"companynumb": "US-JNJFOC-20170526155",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "RIVAROXABAN"
},
"drugadditional": null,
... |
{
"abstract": "An increase in amoxicillin-induced crystal nephropathy (AICN) incidence has been recently suggested. The aims of this study were to investigate the trend of AICN incidence through Paris' regional centers of pharmacovigilance (Paris RCPVs) and better describe this rare adverse drug reaction. Forty-five ... | [
{
"companynumb": "FR-MICRO LABS LIMITED-ML2019-01275",
"fulfillexpeditecriteria": "1",
"occurcountry": "FR",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "AMOXICILLIN\\CLAVULANIC ACID"
},
"dr... |
{
"abstract": "BACKGROUND\nThe aim of this paper is to report maternal and neonatal outcomes in pregnant women treated with escitalopram during pregnancy and breastfeeding.\n\n\nMETHODS\nWomen enrolled in the DEGRA Database at the Clinic of Affective Disorders in Pregnancy and Postpartum in Italy, treated during preg... | [
{
"companynumb": "IT-MYLANLABS-2013S1025458",
"fulfillexpeditecriteria": "1",
"occurcountry": "IT",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "PAROXETINE\\PAROXETINE HYDROCHLORIDE"
},
"dru... |
{
"abstract": "To illustrate that patients with diabetic retinopathy who are treated exclusively with anti-vascular endothelial growth factor (VEGF) therapy and have an interruption in treatment may experience marked progression of disease with potentially devastating visual consequences.\n\n\n\nRetrospective, multic... | [
{
"companynumb": "US-ROCHE-2414348",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "AFLIBERCEPT"
},
"drugadditional": "3",
"drug... |
{
"abstract": "A 67-year-old gentleman developed persistent Staphylococcus epidermidis bacteraemia following transjugular intrahepatic portal shunting. 'Endotipsitis' was diagnosed. Conventional therapy with a vancomycin infusion, amikacin and rifampicin failed after 17 days. He was cured with a 6-week course of high... | [
{
"companynumb": "GB-MYLANLABS-2015M1010598",
"fulfillexpeditecriteria": "1",
"occurcountry": "GB",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "RIFAMPIN"
},
"drugadditional": null,
... |
{
"abstract": "Wilkie's syndrome or superior mesenteric artery syndrome is an unusual cause of proximal intestinal obstruction, primarily attributed to recent weight loss. We report the case of a 19-year-old woman comes to our clinic and reports weight loss, abdominal pain, nausea, and vomiting. Laboratory tests reve... | [
{
"companynumb": "MX-LUPIN PHARMACEUTICALS INC.-2021-26755",
"fulfillexpeditecriteria": "1",
"occurcountry": "MX",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "LEVOTHYROXINE"
},
"drugadditio... |
{
"abstract": "Encephalopathy is a rare side effect of cephalosporin treatment. We herein present a case of encephalopathy induced by ceftriaxone, a third-generation cephalosporin, in a patient with renal failure. An 86-year-old woman on maintenance hemodialysis received ceftriaxone for Helicobacter cinaedi bacteremi... | [
{
"companynumb": "JP-PFIZER INC-2019095052",
"fulfillexpeditecriteria": "1",
"occurcountry": "JP",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "CEFTRIAXONE SODIUM"
},
"drugadditional": "1",
... |
{
"abstract": "Introduction Amplitude-integrated electroencephalography (aEEG) is one of the most widely used neuromonitoring tools in neonatology today. However, little is known about its clinical indications and potential benefits in pediatric intensive care patients. Based on limited experience, its impact on ther... | [
{
"companynumb": "DE-UCBSA-2017022320",
"fulfillexpeditecriteria": "1",
"occurcountry": "DE",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "PHENYTOIN"
},
"drugadditional": "1",
"dru... |
{
"abstract": "An 83-year-old woman was referred to hospital with a 2-week history of short-lived episodic unpleasant sensations in her head and running down her body. This was accompanied by new short-term memory impairment and arm spasms. Initial investigations including blood tests and brain imaging did not reveal... | [
{
"companynumb": "GB-TEVA-2021-GB-1890594",
"fulfillexpeditecriteria": "1",
"occurcountry": "GB",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "CHOLECALCIFEROL"
},
"drugadditional": "3",
... |
{
"abstract": "American trypanosomiasis, also named Chagas disease (CD), is an anthropozoonosis caused by the protozoan parasite Trypanosoma cruzi. The disease affects millions of people worldwide, leading yearly to approximately 50,000 deaths. COVID-19, generated by SARS-CoV-2, can lead to lymphopenia and death. We ... | [
{
"companynumb": "BR-SUN PHARMACEUTICAL INDUSTRIES LTD-2021R1-278481",
"fulfillexpeditecriteria": "1",
"occurcountry": "BR",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "METHYLPREDNISOLONE"
},
... |
{
"abstract": "Despite the successes of tyrosine kinase inhibitors (TKIs) in improving outcomes in patients with chronic myeloid leukemia (CML) and Philadelphia-positive acute lymphoblastic leukemia (Ph + ALL), allogeneic hematopoietic stem cell transplantation (HSCT) continues to be an important and potentially cura... | [
{
"companynumb": "PHHY2014US167142",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "IMATINIB"
},
"drugadditional": null,
"druga... |
{
"abstract": "Glutamic acid decarboxylase antibodies (GAD-Abs) have been implicated in refractory epilepsy. The association with refractory status epilepticus in adults has been rarely described. We discuss our experience in managing three adult patients who presented with refractory status epilepticus associated wi... | [
{
"companynumb": "US-UCBSA-2016011589",
"fulfillexpeditecriteria": "2",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "CLONAZEPAM"
},
"drugadditional": "3",
"dr... |
{
"abstract": "BACKGROUND\nCollagenous colitis (CC) is a clinicopathologic syndrome characterized by chronic watery diarrhea and distinctive histopathologic features. Spontaneous perforation of CC is extremely rare, because CC is usually managed medically, and the need for surgical intervention is rare. We report a s... | [
{
"companynumb": "JP-INVENTIA-000292",
"fulfillexpeditecriteria": "1",
"occurcountry": "JP",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "PREDNISOLONE"
},
"drugadditional": "3",
"d... |
{
"abstract": "The Hyper-CVAD/Methotrexate-Cytarabine (H-CVAD/MTX-AraC) chemotherapy protocol has been one of the standard treatments for blood cancers, such as Mantle cell lymphoma (MCL), Burkitt's lymphoma (BL) and B-cell and T-cell acute lymphoblastic leukaemia (ALL). Due to high toxicity, it has been progressivel... | [
{
"companynumb": "ES-PFIZER INC-2021771271",
"fulfillexpeditecriteria": "1",
"occurcountry": "ES",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "DOXORUBICIN HYDROCHLORIDE"
},
"drugadditional"... |
{
"abstract": "Histoplasma capsulatum is an environmental fungus commonly found in the Ohio and Mississippi River valleys, Central and South America, and Asia. The most affected areas in Argentina are the Paraná and de La Plata river basins. Patients with histoplasmosis can have a wide range of clinical presentations... | [
{
"companynumb": "AR-TEVA-2021-AR-1986844",
"fulfillexpeditecriteria": "1",
"occurcountry": "AR",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "METHOTREXATE"
},
"drugadditional": "3",
... |
{
"abstract": "We present a case of endobronchial fusariosis following bilateral sequential lung transplantation for idiopathic pulmonary arterial hypertension in a 13 years old boy who was treated successfully with posaconazole and nebulized amphotericin B. We discuss the role of nebulized amphotericin B in treating... | [
{
"companynumb": "AU-009507513-1901AUS011665",
"fulfillexpeditecriteria": "1",
"occurcountry": "AU",
"patient": {
"drug": [
{
"actiondrug": "3",
"activesubstance": {
"activesubstancename": "POSACONAZOLE"
},
"drugadditional": null,
... |
{
"abstract": "Crizotinib is an oral small-molecule inhibitor of anaplastic lymphoma kinase (ALK) tyrosine-kinase that has been approved for treating patients with advanced echinoderm microtubule associated protein like 4-ALK rearranged non-small-cell lung cancer (NSCLC). Toxic epidermal necrolysis (TEN) is a rare ad... | [
{
"companynumb": "CN-PFIZER INC-2017471842",
"fulfillexpeditecriteria": "1",
"occurcountry": "CN",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "CRIZOTINIB"
},
"drugadditional": null,
... |
{
"abstract": "We present a case of common challenges in assessment and treatment of substance use disorders in patients with advanced heart failure requiring left ventricular assist device (LVAD). Top experts in the field of consultation-liaison psychiatry, cardiology, and cardiac surgery provide guidance for this c... | [
{
"companynumb": "US-NOVARTISPH-NVSC2022US132586",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "QUETIAPINE"
},
"drugadditional": "3",
... |
{
"abstract": "A 71-year-old man presented with ulcerating yellow-red plaques of the back, chest, face, and extremities (Figure 1). He had a 10-year history of these lesions. The initial plaque appeared on the back followed by rapid progression of multiple similar lesions involving the face, chest, abdomen, and extre... | [
{
"companynumb": "US-JNJFOC-20130712043",
"fulfillexpeditecriteria": "2",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "CLADRIBINE"
},
"drugadditional": null,
... |
{
"abstract": "Androgen deprivation therapy (ADT) is the mainstay of therapy for advanced prostate cancer. Studies addressing the efficacy of different depot formulations of long acting luteinizing hormone releasing hormone agonists in the Brazilian population are lacking. We aimed to compare the efficacy of three sc... | [
{
"companynumb": "BR-TOLMAR, INC.-20BR020872",
"fulfillexpeditecriteria": "1",
"occurcountry": "BR",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "LEUPROLIDE ACETATE"
},
"drugadditional": "3"... |
{
"abstract": "BACKGROUND\nPatients with relapsed diffuse large B-cell lymphoma (DLBCL) have a poor prognosis. Gemcitabine, methylprednisolone, cisplatin +/- rituximab (GEM-P+/-R) is a salvage regimen with limited overlap in toxicity with first-line therapy and short duration of inpatient delivery.\n\n\nMETHODS\nWe a... | [
{
"companynumb": "GB-MYLANLABS-2015M1044260",
"fulfillexpeditecriteria": "1",
"occurcountry": "GB",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "CISPLATIN"
},
"drugadditional": null,
... |
{
"abstract": "BACKGROUND\nHemophagocytic lymphohistiocytosis is a disease process characterized by unregulated hyperactivation of the immune system associated with multiorgan involvement and high mortality rates. Early recognition is crucial and a recently validated diagnostic schema, the H-Score, may facilitate dia... | [
{
"companynumb": "PHHY2017US048289",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "PAZOPANIB"
},
"drugadditional": "3",
"drugad... |
{
"abstract": "BACKGROUND\nIn Turkey, pharmacovigilance began in 1985. A fully structured adverse drug reaction (ADR)-reporting system was established with the publication of the first pharmacovigilance regulation in 2005. Subsequent regulation published in 2014 brought further improvements to the system.\n\n\nOBJECT... | [
{
"companynumb": "TR-GILEAD-2016-0226660",
"fulfillexpeditecriteria": "1",
"occurcountry": "TR",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "TENOFOVIR DISOPROXIL FUMARATE"
},
"drugadditiona... |
{
"abstract": "Clozapine is a dibenzodiazepine antipsychotic used for resistant schizophrenia, which is known to be associated with side effects such as agranulocytosis, seizures, weight gain, and less commonly myocarditis/ cardiomyopathy. We present a case of a 20-year-old female who presented with chest pain, short... | [
{
"companynumb": "US-ACCORD-153075",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "CLOZAPINE"
},
"drugadditional": "1",
"drugad... |
{
"abstract": "Tumor lysis syndrome(TLS)induced by chemotherapy for solid tumors is rare. We report a case of a 59-year-old woman with breast cancer who developed TLS. She underwent surgery to treat breast cancer in 1992. 19 years after surgery, however, she was diagnosed with multiple bone metastases(disease free in... | [
{
"companynumb": "JP-SUN PHARMACEUTICAL INDUSTRIES LTD-2016R1-113568",
"fulfillexpeditecriteria": "1",
"occurcountry": "JP",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "GEMCITABINE\\GEMCITABINE HYDROCHLORIDE"
... |
{
"abstract": "Progressive multifocal leukoencephalopathy (PML) is a rare fatal central nervous system disorder characterized by infection-induced demyelination of white matter due to the opportunistic reactivation of John Cunningham virus in an immunocompromised patient. PML is associated with many immune-mediated d... | [
{
"companynumb": "US-ROCHE-2716407",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "PREDNISONE"
},
"drugadditional": "3",
"druga... |
{
"abstract": "We present a case of a 43-year-old female patient with clinical stage IIIB (T3N2M0) anaplastic lymphoma kinase (ALK)-positive adenocarcinoma of the lung. Surgery was not performed initially because of multiple mediastinal lymph nodes invasion, although the mass was technically resected. With the assess... | [
{
"companynumb": "CN-ACCORD-207125",
"fulfillexpeditecriteria": "1",
"occurcountry": "CN",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "CISPLATIN"
},
"drugadditional": "3",
"drugad... |
{
"abstract": "BACKGROUND Thrombocytopenia is a potentially treatment-limiting adverse event of particular interest with the PARP inhibitor niraparib. This adverse event may necessitate niraparib dose reduction or treatment discontinuation, resulting in suboptimal treatment outcomes. Here, we report on niraparib dose... | [
{
"companynumb": "NVSC2021US055469",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "CARBOPLATIN"
},
"drugadditional": "3",
"drug... |
{
"abstract": "OBJECTIVE\nWhen we published the diagnostic criteria for \"ictal epileptic headache\" in 2012, we deliberately and consciously chose to adopt restrictive criteria that probably underestimate the phenomenon, rather than spread panic among patients and physicians who are reluctant to accept this entity.\... | [
{
"companynumb": "IT-JNJFOC-20150918532",
"fulfillexpeditecriteria": "1",
"occurcountry": "IT",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "IBUPROFEN"
},
"drugadditional": null,
"... |
{
"abstract": "This study sought to determine the prevalence, predictors, prognostic relevance and evolution of pulmonary hypertension (PH) (mean pulmonary artery pressure ≥25 mm Hg) in adult patients with a subaortic right ventricle (RV) in a biventricular circulation (2V-RV).\n\n\n\nWe analysed retrospective data f... | [
{
"companynumb": "BE-MYLANLABS-2020M1059904",
"fulfillexpeditecriteria": "1",
"occurcountry": "CA",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "BOSENTAN"
},
"drugadditional": "3",
... |
{
"abstract": "Tendon or muscle rupture is a rare complication of statins that could potentially be disabling and result in a significant burden to patients. The co-administration of statin and gemfibrozil should warrant prescribers' awareness of tendon-related complications of statin use, particularly in high-risk p... | [
{
"companynumb": "US-PFIZER INC-2019394901",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "GEMFIBROZIL"
},
"drugadditional": "1",
... |
{
"abstract": "Although patients with cancer and immunosuppression are at a risk of functional hyposplenism, how to detect it promptly remains unclear. Since hyposplenism allows erythrocytes with nuclear remnants (Howell-Jolly bodies [HJBs]) to appear in the peripheral blood, HJB detection by a routine microscopic ex... | [
{
"companynumb": "JP-BAXTER-2021BAX000778",
"fulfillexpeditecriteria": "1",
"occurcountry": "JP",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "PREDNISOLONE"
},
"drugadditional": "3",
... |
{
"abstract": "Depression constitutes the most frequent comorbid condition associated with rheumatoid arthritis (RA), with prevalence rates ranging from 14% to 48%. This wide range can be explained by several factors including subtypes of depression considered, instrument of measure (i.e. self-questionnaires versus c... | [
{
"companynumb": "DE-LUPIN PHARMACEUTICALS INC.-2020-05197",
"fulfillexpeditecriteria": "2",
"occurcountry": "DE",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "DICLOFENAC"
},
"drugadditional... |
{
"abstract": "Infliximab and adalimumab are widely used in the treatment of patients with ulcerative colitis (UC). There are few published data on the treatment persistence of infliximab and adalimumab in patients with UC.\n\n\n\nWe aimed to compare the treatment persistence rates of infliximab versus adalimumab as ... | [
{
"companynumb": "FR-JNJFOC-20190819563",
"fulfillexpeditecriteria": "1",
"occurcountry": "FR",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "INFLIXIMAB"
},
"drugadditional": null,
... |
{
"abstract": "Sublingual buprenorphine/naloxone, a common treatment for opioid dependence, is frequently abused by intravenous injection. Inadvertent intra-arterial injection of buprenorphine/naloxone can produce acute ischemic insult to the hand due to gelatin embolism. Our purpose was to review a series of these p... | [
{
"companynumb": "US-TEVA-2019-US-997368",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "BUPRENORPHINE\\NALOXONE"
},
"drugadditional": "3... |
{
"abstract": "BACKGROUND\nPriapism is a common concern in sickle cell disease. With a high frequency of recurrences and serious long-term sequela, a preventative, rather than traditionally reactive approach, needs to be taken in these patients. Reports have shown successful use of sildenafil as a prophylactic treatm... | [
{
"companynumb": "US-PFIZER INC-2011222763",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "SILDENAFIL CITRATE"
},
"drugadditional": "1",
... |
{
"abstract": "Malakoplakia (from the Greek malakos, 'soft' and plakos 'plaque') is a granulomatous inflammatory condition, commonly presenting as a plaque in the genitourinary system, but has been shown to affect a wide variety of structures including the skin. Presentation is varied and a high degree of clinical su... | [
{
"companynumb": "NVSC2019GB015927",
"fulfillexpeditecriteria": "1",
"occurcountry": "GB",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "MYCOPHENOLIC ACID"
},
"drugadditional": "3",
... |
{
"abstract": "OBJECTIVE\nTo report a case of acute hepatic injury and acute renal failure secondary to rhabdomyolysis associated with fluvastatin-gemfibrozil combination therapy for hyperlipidemia.\n\n\nMETHODS\nA 56-year-old woman with a history of hyperlipidemia presented with fatigue, weakness in her lower extrem... | [
{
"companynumb": "TR-PFIZER INC-2019227392",
"fulfillexpeditecriteria": "1",
"occurcountry": "TR",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "FLUVASTATIN SODIUM"
},
"drugadditional": "1",
... |
{
"abstract": "We present the case of a 35-year-old man with thoracic back pain and stiffness, whose only medical history was cystic acne treated with repeated courses of retinoids. His thoracic spine was severely limited in range of movement and was found, on X-ray, to have unilateral hyperostosis typical of diffuse... | [
{
"companynumb": "GB-AKORN PHARMACEUTICALS-2015AKN00514",
"fulfillexpeditecriteria": "1",
"occurcountry": "GB",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "ISOTRETINOIN"
},
"drugadditional"... |
{
"abstract": "The pharmacokinetics of temozolomide (TMZ) in patients with severe renal impairments (creatinine clearance, <36 mL/min/m2) or in hemodialysis (HD) patients has not been investigated. TMZ and its metabolic products are mainly excreted in urine, as retention of these in the body may result in increased a... | [
{
"companynumb": "JP-ACCORD-172993",
"fulfillexpeditecriteria": "1",
"occurcountry": "JP",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "TEMOZOLOMIDE"
},
"drugadditional": null,
"dr... |
{
"abstract": "Background: Human epidermal growth factor receptor 2 (ERBB2, HER-2) exon 20 insertion (ERBB2ex20ins) remains a refractory oncogenic driver in lung cancer. So far there is limited data showing the co-occurring mutation background of ERBB2ex20ins in Chinese lung cancer and its relationship with response ... | [
{
"companynumb": "CN-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2020-BI-028577",
"fulfillexpeditecriteria": "1",
"occurcountry": "CN",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "AFATINIB"
},
"dr... |
{
"abstract": "Medical assistance in dying (MAID) and similar right-to-die laws are becoming increasingly common in jurisdictions across North America and elsewhere. To be eligible for MAID in Canada, requesters must have a serious illness, intolerable suffering, and a reasonably foreseeable natural death. They must ... | [
{
"companynumb": "CA-PFIZER INC-2020366187",
"fulfillexpeditecriteria": "1",
"occurcountry": "CA",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "DILTIAZEM"
},
"drugadditional": null,
... |
{
"abstract": "Asparaginase plays an integral role in chemotherapy for acute lymphoblastic leukemia (ALL). We present a 69-year old woman with refractory ALL, who developed asparaginase-induced hepatotoxicity and cholangiopathy after starting intravenous PEG-L-asparaginase-based chemotherapy. The patient was ultimate... | [
{
"companynumb": "US-SERVIER-S21010604",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "PEGASPARGASE"
},
"drugadditional": "3",
... |
{
"abstract": "BACKGROUND\nSteroidogenesis inhibitors, such as ketoconazole (KTZ) and metyrapone (MTP), are used to lower hypercortisolism in patients with Cushing's syndrome (CS). Cortisol normalization is not reached in all patients taking these medications.\n\n\nOBJECTIVE\nTo test the hypothesis that variants in g... | [
{
"companynumb": "ES-JNJFOC-20171128990",
"fulfillexpeditecriteria": "1",
"occurcountry": "ES",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "KETOCONAZOLE"
},
"drugadditional": "3",
... |
{
"abstract": "BACKGROUND\nWilson disease (WD) is an autosomal recessive hereditary disease in which the patient usually has a reduced risk of developing cancer. In particular, with the exception of hepatocellular carcinoma and cholangiocarcinoma, the incidence of cancer is significantly lower in WD patients compared... | [
{
"companynumb": "CN-PFIZER INC-2019246702",
"fulfillexpeditecriteria": "1",
"occurcountry": "CN",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "PACLITAXEL"
},
"drugadditional": "3",
... |
{
"abstract": "Wilms tumor, or nephroblastoma, is the most common malignant tumor of the urinary tract in children, but is rarely found in adults. Here, we report the first case of a female patient with a Wilms tumor, diagnosed during pregnancy, who underwent radical nephrectomy and adjuvant chemotherapy before and a... | [
{
"companynumb": "DE-RECORDATI RARE DISEASES INC.-DKLU1060502",
"fulfillexpeditecriteria": "1",
"occurcountry": "DE",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "DACTINOMYCIN"
},
"drugaddi... |
{
"abstract": "Pyoderma gangrenosum is a sterile inflammatory disease of unknown etiology characterized by recurrent cutaneous ulcers. It can occur in extracutaneous locations, especially at operative sites, and has been reported following gynecologic surgery. This report is the first case of pyoderma gangrenosum as ... | [
{
"companynumb": "US-STRIDES ARCOLAB LIMITED-2021SP029115",
"fulfillexpeditecriteria": "2",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "4",
"activesubstance": {
"activesubstancename": "METRONIDAZOLE"
},
"drugaddition... |
{
"abstract": "Necrotising myopathy is an autoimmune disease that commonly affects muscles. Here we examine a case of a middle-aged women presenting with a chief report of shortness of breath, who subsequently developed muscle weakness. Her clinical course was complicated by respiratory failure and pulmonary hyperten... | [
{
"companynumb": "US-HIKMA PHARMACEUTICALS USA INC.-US-H14001-21-03794",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": null,
"drugadditional": null,
"drugadministrationroute"... |
{
"abstract": "Coronavirus disease 2019 (COVID-19) has spread to more than 70 countries around the world since its discovery in 2019. More than 2.5 million cases and more than 130,000 deaths have been reported in the United States alone. The common radiological presentation in this disease is noted to be the presence... | [
{
"companynumb": "US-SUN PHARMACEUTICAL INDUSTRIES LTD-2021R1-293681",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "HYDROXYCHLOROQUINE"
},
... |
{
"abstract": "Human immunodeficiency virus-infected patients are at increased risk of drug reactions because of immune dysregulation and multiple drug intake. Lichenoid drug reactions to isoniazid have been reported previously in the literature. However, for lichenoid drug reaction to isoniazid to be so extensive to... | [
{
"companynumb": "IN-WATSON-2015-24043",
"fulfillexpeditecriteria": "1",
"occurcountry": "IN",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "SULFAMETHOXAZOLE\\TRIMETHOPRIM"
},
"drugadditiona... |
{
"abstract": "Propranolol emerged as the first-line therapy for infantile hemangioma (IH). Determinants of interindividual variation in drug response and predictors of rebound growth after drug discontinuation are yet to be firmly established. We aimed to evaluate the outcomes of a relatively large cohort of patient... | [
{
"companynumb": "IL-INNOGENIX, LLC-2120277",
"fulfillexpeditecriteria": "1",
"occurcountry": "IL",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "PROPRANOLOL HYDROCHLORIDE"
},
"drugadditional... |
{
"abstract": "BACKGROUND\nTamoxifen is often used as antihormonal therapy in patients with breast cancer. However, it has various side effects, of which pneumonia is a rare occurrence.\n\n\nMETHODS\nA 46-year-old female patient with breast cancer underwent surgical treatment. Tamoxifen was administered as adjuvant t... | [
{
"companynumb": "KR-TEVA-2019-KR-1081469",
"fulfillexpeditecriteria": "1",
"occurcountry": "KR",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "TAMOXIFEN"
},
"drugadditional": "1",
... |
{
"abstract": "OBJECTIVE\nCiprofloxacin is considered to be a safe and effective treatment for acute infectious colitis. However, this drug may cause drug-induced pancreatitis, albeit rarely.\n\n\nMETHODS\nFrom March 2007 to February 2012, we studied 227 patients who were hospitalized for infectious colitis at St. Ma... | [
{
"companynumb": "KR-LUPIN PHARMACEUTICALS INC.-2014-01801",
"fulfillexpeditecriteria": "2",
"occurcountry": "KR",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "CIPROFLOXACIN"
},
"drugadditio... |
{
"abstract": "Anti-N-methyl-D-aspartate receptor (NMDAR) encephalitis is a serious autoimmune disorder characterized by psychiatric symptoms, seizures and movement disorder. Predisposing factors have been reported since the time it was described, and its pathophysiology has been tried to be clarified over the years.... | [
{
"companynumb": "TR-TEVA-2019-TR-1118457",
"fulfillexpeditecriteria": "1",
"occurcountry": "TR",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "NATALIZUMAB"
},
"drugadditional": null,
... |
{
"abstract": "Long-term survival of liver transplant recipients is endangered by tumorigenesis at different sites. Little is known about primary de novo tumors developing in the graft.\nWe analyzed the follow-up data of 2731 liver recipients that were transplanted between 1988 and 2019 at our institution (Charité - ... | [
{
"companynumb": "DE-GILEAD-2021-0541453",
"fulfillexpeditecriteria": "1",
"occurcountry": "DE",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "TENOFOVIR DISOPROXIL"
},
"drugadditional": "3",
... |
{
"abstract": "Second-line chemotherapy is not a standard of care in patients with malignant pleural mesothelioma (MPM) that progresses after first-line treatment with cisplatin and pemetrexed. In pre-clinical models, the combination of gemcitabine (GEM) and imatinib mesylate (IM), compared with GEM alone, led to a f... | [
{
"companynumb": "NVSC2020IT066291",
"fulfillexpeditecriteria": "1",
"occurcountry": "IT",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "GEMCITABINE"
},
"drugadditional": null,
"dru... |
{
"abstract": "Kaposi sarcoma is a mesenchymal tumor associated to a human herpes virus-8. It often occurs in human immunodeficiency virus-positive subjects. Colorectal localization is rare. We report the case of a colorectal Kaposi sarcoma complicating a refractory ulcerative colitis treated with surgery after the f... | [
{
"companynumb": "TN-WATSON-2014-16636",
"fulfillexpeditecriteria": "1",
"occurcountry": "TN",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "PREDNISONE"
},
"drugadditional": null,
... |
{
"abstract": "Given the limited curative treatment options for recurrent lung cancer patients, the aim of our retrospective study was to investigate whether these patients would benefit in terms of overall survival (OS) by adding immunotherapy to high-dose reirradiation.\n\n\n\nBetween 2013 and 2019, 47 consecutive ... | [
{
"companynumb": "AT-ROCHE-2777561",
"fulfillexpeditecriteria": "1",
"occurcountry": "AT",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "CISPLATIN"
},
"drugadditional": "3",
"drugad... |
{
"abstract": "Malignant pleural mesothelioma (MPM) is an asbestos-related tumor arising in the pleural cavity. Symptoms reflect extension of disease and include shortness of breath and chest pain. Unexplained pleural effusion and pleural pain in patients exposed to asbestos should raise the suspicion of MPM. The mos... | [
{
"companynumb": "US-TEVA-2019-US-1010356",
"fulfillexpeditecriteria": "2",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "IBUPROFEN"
},
"drugadditional": "3",
... |
{
"abstract": "A seven years old girl presented with history of sudden onset of generalized body weakness to an extent that she was not able to move any body part. On thorough history it was revealed that she was given intramuscular injection lincomycin at private clinic which lead to neuromuscular paralysis of whole... | [
{
"companynumb": "PK-PFIZER INC-2015109394",
"fulfillexpeditecriteria": "1",
"occurcountry": "PK",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "LINCOMYCIN HYDROCHLORIDE"
},
"drugadditional"... |
{
"abstract": "OBJECTIVE\nTo describe the long-term outcomes of intravitreal bevacizumab (IVB) for the treatment of pediatric retinal and choroidal diseases.\n\n\nMETHODS\nThis was a multicenter, retrospective, consecutive case series of patients <18 years of age treated with IVB from 2005 to 2013. Primary outcome me... | [
{
"companynumb": "US-ROCHE-1399195",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "BEVACIZUMAB"
},
"drugadditional": "3",
"drug... |
{
"abstract": "Data from clinical trials do not always provide adequate information to judge the impact of new treatments when used in a real-world setting. The aim of our study was to analyze adverse events (AEs) associated with enzalutamide (ENZ) and abiraterone (ABI) using real-life data from the EudraVigilance (E... | [
{
"companynumb": "IT-JNJFOC-20190512256",
"fulfillexpeditecriteria": "1",
"occurcountry": "IT",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "PREDNISOLONE"
},
"drugadditional": null,
... |
{
"abstract": "Anticoagulants are commonly prescribed in medical practices and could be of significant harm in the case of medication errors. We conducted a retrospective observational study to determine the frequency and consequences of the therapeutic duplication of anticoagulants (TDA). As a secondary objective, w... | [
{
"companynumb": "CH-TEVA-2020-CH-1858004",
"fulfillexpeditecriteria": "1",
"occurcountry": "CH",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "DALTEPARIN"
},
"drugadditional": null,
... |
{
"abstract": "OBJECTIVE\nTo review special safety topics associated with sildenafil and to document the tolerability of 50- and 100-mg doses, overall and by age, in men with erectile dysfunction (ED).\n\n\nMETHODS\nData were collated from 67 double-blind placebo-controlled (DBPC) trials (> 14,000 men) conducted by t... | [
{
"companynumb": "FR-ALKEM LABORATORIES LIMITED-FR-ALKEM-2022-03147",
"fulfillexpeditecriteria": "1",
"occurcountry": "FR",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "SILDENAFIL"
},
"druga... |
{
"abstract": "Pulmonary sarcomatoid carcinoma is a rare, poorly differentiated, and highly aggressive type of non-small cell lung cancer. High tumor mutational burden and PD-L1 overexpression make it an excellent candidate for immunotherapy.\nWe presented the case of a patient who underwent left inferior lobectomy w... | [
{
"companynumb": "IT-ACCORD-104250",
"fulfillexpeditecriteria": "1",
"occurcountry": "IT",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "DOCETAXEL"
},
"drugadditional": "3",
"drugad... |
{
"abstract": "Outcomes in patients with Philadelphia chromosome (Ph)-positive acute lymphoblastic leukemia (ALL) have improved with the use of tyrosine kinase inhibitors. Molecular remission is a primary goal of treatment.\n\n\n\nWe conducted a phase 2 single-group trial of first-line therapy in adults with newly di... | [
{
"companynumb": "IT-AMGEN-ITASP2019157218",
"fulfillexpeditecriteria": "2",
"occurcountry": "IT",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "BLINATUMOMAB"
},
"drugadditional": null,
... |
{
"abstract": "A 24-year-old pregnant woman (29.4 weeks of gestation) with A (H1N1) influenza-associated adult respiratory distress syndrome was admitted to the intensive care unit. The patient was connected to femoral-jugular veno-venous extracorporeal membrane oxygenation (ECMO) 8 hours after admission. On the 7(th... | [
{
"companynumb": "PL-PFIZER INC-2014202125",
"fulfillexpeditecriteria": "1",
"occurcountry": "PL",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "HEPARIN SODIUM"
},
"drugadditional": null,
... |
{
"abstract": "BACKGROUND\nPost-transplant lymphoproliferative disorders (PTLDs) represent a spectrum of heterogenetic lymphoid proliferations. PTLD is a serious complication that affects the long-term survival of kidney transplant patients. Imaging examination is an important method for detecting and diagnosing PTLD... | [
{
"companynumb": "CN-HEALTHCARE PHARMACEUTICALS LTD.-2083736",
"fulfillexpeditecriteria": "1",
"occurcountry": "CN",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "PREDNISOLONE"
},
"drugadditi... |
{
"abstract": "BACKGROUND\nThere are several regimens used in hematopoietic stem cell (HSC) mobilization in multiple myeloma (MM). Cyclophosphamide (Cy) is one of the most commonly used agents, although it does not always result in collecting adequate number of CD34+ cells. Recently, cytarabine (Ara-C) has been propo... | [
{
"companynumb": "PL-AMGEN-POLSP2020142366",
"fulfillexpeditecriteria": "2",
"occurcountry": "PL",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "FILGRASTIM"
},
"drugadditional": "3",
... |
{
"abstract": "Exemestane (Exe) in combination with Everolimus (Eve) represents an important treatment option for patients diagnosed with hormone receptor positive (HR+), human epidermal growth factor receptor 2 negative (HER2-) metastatic breast cancer (MBC), which was previously treated with non-steroidal aromatase... | [
{
"companynumb": "IT-MYLANLABS-2018M1067006",
"fulfillexpeditecriteria": "1",
"occurcountry": "IT",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "EXEMESTANE"
},
"drugadditional": "3",
... |
{
"abstract": "Polyomavirus-associated nephropathy (PyVAN) is rare in nonrenal solid organ transplantation and only limited information is available from single cases. We describe a 67-year-old female presenting with hypertension and progressive kidney failure due to PyVAN 60 months after lung transplantation. Plasma... | [
{
"companynumb": "JP-ALKEM LABORATORIES LIMITED-JP-ALKEM-2019-08051",
"fulfillexpeditecriteria": "1",
"occurcountry": "JP",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "MYCOPHENOLATE MOFETIL"
},
... |
{
"abstract": "BACKGROUND\nEpidural steroid injections are frequently used to treat back and extremity pain. The procedure is generally safe, with a low rate of adverse events, including intrathecal entry, pneumocephalus, and chemical meningitis.\n\n\nMETHODS\nWe report a case of a 45-year-old woman who presented to ... | [
{
"companynumb": "US-MYLANLABS-2016M1058741",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "LIDOCAINE"
},
"drugadditional": null,
... |
{
"abstract": "BACKGROUND\nA single injection of pegfilgrastim has been shown to be equivalent to daily filgrastim in enhancing neutrophil recovery after chemotherapy, whereas the experiences with pegfilgrastim in mobilization of peripheral blood progenitor cells (PBPCs) are limited.\n\n\nMETHODS\nForty unselected pa... | [
{
"companynumb": "DE-AMGEN-DEUSP2020018797",
"fulfillexpeditecriteria": "2",
"occurcountry": "DE",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "FILGRASTIM"
},
"drugadditional": null,
... |
{
"abstract": "BACKGROUND\nDrug hypersensitivity is classically divided into IgE mediated and non-IgE mediated disease. We report a rare case of consequent IgE mediated and non-IgE mediated reactions within the beta lactam class of antibiotics.\n\n\nMETHODS\nAn 84-year-old man developed toxic epidermal necrolysis (TE... | [
{
"companynumb": "US-LUPIN PHARMACEUTICALS INC.-2022-07120",
"fulfillexpeditecriteria": "2",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "CEFTRIAXONE"
},
"drugadditiona... |
{
"abstract": "BACKGROUND\nWe report a case of fungal endophthalmitis which developed after subtenon injections of triamcinolone acetonide (TA).\n\n\nMETHODS\nA 63-year-old man had Graves' ophthalmopathy. He had received subtenon injections of TA in his left eye. He was admitted to Kimura Eye & Internal Medicine Hosp... | [
{
"companynumb": "JP-ALKEM LABORATORIES LIMITED-JP-ALKEM-2018-01056",
"fulfillexpeditecriteria": "1",
"occurcountry": "JP",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "TRIAMCINOLONE ACETONIDE"
},
... |
{
"abstract": "Clinically available targeted agents to treat advanced renal cell carcinoma (RCC) include sunitinib, sorafenib and temsirolimus. Sorafenib and sunitinib have been associated with bleeding in selected trials, but clinical and endoscopic characteristics of gastrointestinal bleeding are not well described... | [
{
"companynumb": "JP-MYLANLABS-2016M1000702",
"fulfillexpeditecriteria": "1",
"occurcountry": "JP",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "SUNITINIB"
},
"drugadditional": null,
... |
{
"abstract": "BACKGROUND\nBeyond focal radiation, there is no consensus standard therapy for pediatric high-grade glioma (pHGG) and outcomes remain dismal. We describe the largest molecularly-characterized cohort of children with pHGG treated with a 3-drug maintenance regimen of temozolomide, irinotecan, and bevaciz... | [
{
"companynumb": "US-009507513-1905USA009060",
"fulfillexpeditecriteria": "2",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "TEMOZOLOMIDE"
},
"drugadditional": "3",
... |
{
"abstract": "Schimke immuno-osseous dysplasia (SIOD) is a rare multisystemic disorder with a variable clinical expressivity caused by biallelic variants in SMARCAL1. A phenotype-genotype correlation has been attempted and variable expressivity of biallelic SMARCAL1 variants may be associated with environmental and ... | [
{
"companynumb": "IT-PFIZER INC-2021544556",
"fulfillexpeditecriteria": "1",
"occurcountry": "IT",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "LEVOTHYROXINE"
},
"drugadditional": null,
... |
{
"abstract": "We describe a case of acquired monosomy 7 myelodysplastic syndrome (MDS) in a boy with congenital adrenocortical insufficiency, genital anomalies, growth delay, skin hyperpigmentation, and chronic lung disease. Some of his clinical manifestations were suggestive of dyskeratosis congenita (DC), while ot... | [
{
"companynumb": "US-FRESENIUS KABI-FK201805657",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "FLUDARABINE PHOSPHATE"
},
"drugadditiona... |
{
"abstract": "We present a case report of a 31-year-old female patient who presented to us with a 1 day history of acute bilateral eye pain, blurred vision and headache. She was found to have a myopic shift, raised intraocular pressure (IOP) and shallow anterior chambers in both eyes. She had been commenced on oral ... | [
{
"companynumb": "IN-LUPIN PHARMACEUTICALS INC.-2015-03327",
"fulfillexpeditecriteria": "2",
"occurcountry": "IN",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "TOPIRAMATE"
},
"drugadditional... |
{
"abstract": "BACKGROUND\nWe describe clinical, pathologic, and molecular characteristics of never-smoker patients with small-cell lung cancers (SCLCs).\n\n\nMETHODS\nWe identified cases of SCLCs evaluated at our institution from 2005 to 2012. We collected smoking history, demographic, treatment, and survival data. ... | [
{
"companynumb": "US-MYLANLABS-2015M1008031",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "ERLOTINIB"
},
"drugadditional": null,
... |
{
"abstract": "BACKGROUND\nPrevious randomized controlled trials evaluating the efficacy of mycophenolate mofetil (MMF) in patients with immunoglobulin A nephropathy (IgAN) have produced varying results.\n\n\nMETHODS\nDouble-blind placebo-controlled randomized controlled trial.\n\n\nMETHODS\n52 children, adolescents,... | [
{
"companynumb": "US-STRIDES ARCOLAB LIMITED-2017SP005331",
"fulfillexpeditecriteria": "2",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "MYCOPHENOLATE MOFETIL"
},
"drug... |
{
"abstract": "OBJECTIVE\nTo estimate the prevalence of gestational trophoblastic disease (GTD) in the western region of Saudi Arabia, and to evaluate the success of treatment and the effect of age and risk group on survival.\n\n\nMETHODS\nBetween January 2001 and December 2010, all patients treated for GTD were iden... | [
{
"companynumb": "SA-MYLANLABS-2015M1007950",
"fulfillexpeditecriteria": "1",
"occurcountry": "SA",
"patient": {
"drug": [
{
"actiondrug": "5",
"activesubstance": {
"activesubstancename": "METHOTREXATE"
},
"drugadditional": null,
... |
{
"abstract": "Hoyeraal-Hreidarsson syndrome (HHS), caused by several different germline mutations resulting in severe telomeropathy, presents with early-onset growth anomalies and neurologic/developmental disorders including characteristic cerebellar hypoplasia. Early mortalities may arise from immunodeficiency and ... | [
{
"companynumb": "PHHY2019TW184467",
"fulfillexpeditecriteria": "1",
"occurcountry": "TW",
"patient": {
"drug": [
{
"actiondrug": "4",
"activesubstance": {
"activesubstancename": "CYCLOSPORINE"
},
"drugadditional": null,
"dr... |
{
"abstract": "The prophylactic use of phenytoin during and after brain surgery and cranial irradiation is a common measure in brain tumor therapy. Phenytoin has been associated with variety of adverse skin reactions including urticaria, erythroderma, erythema multiforme (EM), Stevens-Johnson syndrome, and toxic epid... | [
{
"companynumb": "TR-VISTAPHARM, INC.-VER201711-001256",
"fulfillexpeditecriteria": "1",
"occurcountry": "TR",
"patient": {
"drug": [
{
"actiondrug": "1",
"activesubstance": {
"activesubstancename": "PHENYTOIN"
},
"drugadditional": "1... |
{
"abstract": "Despite therapeutic advances in HER2-positive metastatic breast cancer, resistance to trastuzumab inevitably develops. In the PHOEBE study, we aimed to assess the efficacy and safety of pyrotinib (an irreversible pan-HER inhibitor) plus capecitabine after previous trastuzumab.\n\n\n\nThis is an open-la... | [
{
"companynumb": "NVSC2021CN036209",
"fulfillexpeditecriteria": "1",
"occurcountry": "CN",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "LAPATINIB"
},
"drugadditional": null,
"druga... |
{
"abstract": "Intravenous methylprednisolone (IVMP) pulse therapy is the first-line treatment for the active phase of moderate to severe Graves' orbitopathy (GO). However, acute and severe liver damage has been reported during and after IVMP therapy. In this retrospective study, we investigated risk factors for live... | [
{
"companynumb": "JP-PFIZER INC-2015249666",
"fulfillexpeditecriteria": "1",
"occurcountry": "JP",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "PREDNISOLONE"
},
"drugadditional": null,
... |
{
"abstract": "This paper describes the association of two unusual side effects of treatment with isotretinoin for severe acne: paronychia and excess granulation tissue in the nails furrows. We report a case of male patient aged 19 years, who in the course of the 36th week of treatment with isotretinoin for acne grad... | [
{
"companynumb": "BR-MYLANLABS-2016M1023995",
"fulfillexpeditecriteria": "1",
"occurcountry": "BR",
"patient": {
"drug": [
{
"actiondrug": "3",
"activesubstance": {
"activesubstancename": "ISOTRETINOIN"
},
"drugadditional": null,
... |
{
"abstract": "Immunoglobulin G4 (IgG4)-related disease is a systemic autoimmune disease that can affect various organs. Corticosteroid therapy is generally an effective treatment; however, IgG4-related aortic lesions pose a risk of aortic rupture related to corticosteroid use. Here, we report a case of IgG4-related ... | [
{
"companynumb": "PHHY2015JP123078",
"fulfillexpeditecriteria": "1",
"occurcountry": "JP",
"patient": {
"drug": [
{
"actiondrug": "4",
"activesubstance": {
"activesubstancename": "PREDNISOLONE"
},
"drugadditional": null,
"dr... |
{
"abstract": "Radiation necrosis is a potentially debilitating side effect of therapy necessary to treat pediatric central nervous system tumors. Clinical signs of cerebral radiation necrosis (CRN) are similar to symptoms of disease progression and require close monitoring. The case of an infant diagnosed with a mal... | [
{
"companynumb": "US-PFIZER INC-2021377688",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "CYCLOPHOSPHAMIDE"
},
"drugadditional": null,
... |
{
"abstract": "BACKGROUND\nPolyethylene glycols (PEGs) or macrogols are polyether compounds and are widely used as additives in pharmaceuticals, cosmetics, and food.\n\n\nMETHODS\nWe report on a Caucasian patient experiencing recurrent severe allergic reactions to several drugs. An extensive diagnostic workup includi... | [
{
"companynumb": "DE-LANNETT COMPANY, INC.-DE-2018LAN000540",
"fulfillexpeditecriteria": "1",
"occurcountry": "DE",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": null,
"drugadditional": null,
"drugadministrationroute": null,
... |
{
"abstract": "Reporting of adverse incidents is mandatory in Denmark. All reported adverse incidents are made anonymously, and stored in an encrypted database. It is the purpose of this descriptive study to describe the severity of adverse medication incidents caused by oral anticoagulants in hospitals. All moderate... | [
{
"companynumb": "DK-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2017-BI-035078",
"fulfillexpeditecriteria": "1",
"occurcountry": "DK",
"patient": {
"drug": [
{
"actiondrug": null,
"activesubstance": {
"activesubstancename": "ASPIRIN"
},
"dr... |
{
"abstract": "Although poisoning with calcium channel blocking agents is frequent, to our knowledge no cases involving amlodipine have been published. We describe here a case of amlodipine intoxication, in which protracted hypotension did not respond to vasopressor therapy alone. After the addition of continuous cal... | [
{
"companynumb": "US-ALKEM LABORATORIES LIMITED-US-ALKEM-2018-03023",
"fulfillexpeditecriteria": "1",
"occurcountry": "US",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "AMLODIPINE BESYLATE"
},
... |
{
"abstract": "Anti-synthetase syndrome is an autoimmune disorder characterized by the presence of autoantibodies against aminoacyl transfer RNA (tRNA) synthetases, and myositis, interstitial lung disease (ILD), arthritis, fever and Raynaud's phenomenon (RP). We present a 54-year-old woman, who complained of fatigue,... | [
{
"companynumb": "GR-MYLANLABS-2020M1004249",
"fulfillexpeditecriteria": "1",
"occurcountry": "GR",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "CLARITHROMYCIN"
},
"drugadditional": null,
... |
{
"abstract": "Giant cell arteritis is a common systemic vasculitis affecting the elderly, with maximum prevalence in the 7th decade of age, targeting aortic derived medium and large vessels of the neck and head. Diagnosis is established on a biopsy specimen of the temporal artery wall, through pathological confirmat... | [
{
"companynumb": "RO-SUN PHARMACEUTICAL INDUSTRIES LTD-2020RR-237346",
"fulfillexpeditecriteria": "1",
"occurcountry": "RO",
"patient": {
"drug": [
{
"actiondrug": "3",
"activesubstance": {
"activesubstancename": "PREDNISONE"
},
"drug... |
{
"abstract": "Acute liver failure (ALF) in neonates is rare. Although the incidence is reported to be rare, neonatal hemochromatosis (NH) has to be considered as one of the causes of neonatal ALF. We present a pair of dichorionic twin who had a diverse clinical presentation of NH. One twin passed away despite medica... | [
{
"companynumb": "HK-BEH-2021129455",
"fulfillexpeditecriteria": "1",
"occurcountry": "HK",
"patient": {
"drug": [
{
"actiondrug": "6",
"activesubstance": {
"activesubstancename": "HUMAN IMMUNOGLOBULIN G"
},
"drugadditional": null,
... |
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